Antibiotics with QIDP Designation – – – Updated 9-30-14

For the latest QIDP listing, please click HERE


 

Since FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’.  Which should not come as a surprise: QIDP status confers significant benefits – and there is no downside.

While an official FDA list of drugs that have received QIDP “approval” does not seem to exist, several sources speak of approx. 30 compounds that have garnered this designation.FDA

My quick Google search identified 26 compounds.  While most are from known antibiotic drug classes, they all have expanded spectra or PK/PD benefits over existing drugs. Of interest, some compounds have changed hands or entered into co-development deals with large(r) Pharma companies.

UPDATE 3:   Dalbavancin (Dalvance), oritavancin (Orbactiv), and  tedizolid (Sivextro) were recently approved and are no longer listed here.

NOTE:    Some drugs have transitioned from Phase 2 into Phase 3 since the table was first published 2 months ago.

NOTE:  Please search this site for other blogs related to QIDP;
the latest update is from 3/28/2015, with a searchable table of all drugs

The table below lists only systemic drugs in Phases 2 or 3 which garnered the QIDP designation.  MK-7655 (Relebactam) is the most recent addition to our list. Interestingly, there are no new antibiotic classes on the list; the group of FabI inhibitors (there are at least 3 in development) so far did not seek or has not received QIDP status.

Drug NameCompanyPhaseAntibiotic Class
AvarofloxacinActavisPhase 2quinolone
Ceftazidime + avibactamActavisPhase 3B-lactam / BLI
Ceftolozane + tazobactamCubistPhase 3B-lactam / BLI
DelafloxacinMelintaPhase 3quinolone
EravacyclineTetraphasePhase 3tetracycline
FinafloxacinMerLionPhase 2quinolone
Fusidic AcidCempraPhase 2fusidic acid
Imipenem/cilastatin + MK-7655MerckPhase 2B-lactam / BLI
Meropenem + RPX7009The Medicines Comp (Rempex)Phase 3B-lactam / BLI
NemonoxacinTaiGen BiotechnologyPhase 3quinolone
OmadacyclineParatekPhase 2tetracycline
PlazomicinAchaogenPhase 3aminoglycoside
RadezolidMelintaPhase 2oxazolidinone
SolithromycinCempraPhase 3macrolide / ketolide

CORRECTED: 9/30//2014

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2 Replies to “Antibiotics with QIDP Designation – – – Updated 9-30-14”

    • Thanks for pointing this out: Polymedx’ Brilacidin (now with Cellceutix) has been granted QIDP status Dec. 8th, 2014. It will be added to the list with the next update.

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